Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-10 are pending and examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of decreasing sleep latency, sleep duration or increasing NREM sleep, does not reasonably provide enablement for preventing a sleep disorder disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Claims 1-10 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a formulation for treating decreasing sleep latency, sleep duration or increasing NREM sleep, does not does not reasonably provide enablement for preventing a sleep disorder disease, including, for instance, Fatal Familia Insomnia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method used for prevention or treating decreasing sleep latency, sleep duration or increasing NREM sleep. The specification teaches sleep disorder therapy with drugs and non-drug treatments. However, a congenital birth defect, which is a risk factor for Fatal Familia Insomnia (see https://my.clevelandclinic.org/health/diseases/25001-fatal-familial-insomnia), cannot be prevented by these pathways. Thus, the claims taken together with the specification imply that Applicants are claiming for preventing all sleep disorder diseases without showing any experiment data to support the prevention of sleep disorder diseases.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art is unpredictable with regard to prevention of sleep disorder including, for example, Fatal Familia Insomnia. The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work (see MPEP § 2164.04).
(5) The relative skill of those in the art:
The relative skill of those in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has disclosed sleep disorder activity in fruit flies [0089, Example 5]. However, the specification has not disclosed any examples or any evidence of prevention of Fatal Familia Insomnia, the specification does not disclose that the method of the claims is all sleep disorder diseases, including, for example, Fatal Familia Insomnia.
(8) The quantity of experimentation necessary:
Considering the high unpredictability and the lack of guidance provided in the specification with regard to prevention of Fatal Familia Insomnia instantly claimed, one of ordinary skill in the art would be burdened with undue experimentation to determine all of the prevention of all sleep disorder diseases; therefore, the treatment would be unpredictable.
Please note that the rejection above can be overcome by omitting “preventing” from the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (KR 101434994 B1).
Kim et al. teaches a method of treating people with obesity sleep disorder (Background Art paragraph 2) with extract of Dendropanax mobifera as the active ingredient by extracting in 96 g ethanol in 138 g water, which is 70% ethanol (Example 1). The same ethanol extract of Dendropanax mobifera would contain the same amounts of cholorgenic acid and rutin in Claims 3 and 4 and other active ingredients in Claim 5 and would have the same biological effects in Claim 9. People with obesity would be a subject in need thereof in Claim 10. Sleep disorder would include the types in Claims 6 and 7.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655